REGN5381 in Adult Participants With Uncontrolled Hypertension

Launched by REGENERON PHARMACEUTICALS · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called REGN5381 to see if it can help lower high blood pressure in adults who still have high readings despite taking other blood pressure medications. The trial will be conducted in two parts, starting with Part A, and aims to explore how well the drug works, any side effects that might occur, how the body processes the drug, and whether the body develops antibodies that could affect the drug's effectiveness.

To participate in this trial, adults aged between 40 and 85 need to have high blood pressure readings of 130 to 180 mm Hg while on stable blood pressure medications for at least a month. Younger adults aged 30 to 39 may also qualify if they are taking at least three blood pressure medications. However, there are some health conditions that would exclude someone from joining, such as having a very fast heart rate or certain liver and kidney issues. Participants will receive the study drug and will be monitored for any side effects and changes in their blood pressure throughout the study. If you or someone you know is interested, it's a good opportunity to contribute to research that may help others with similar health challenges.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Adults with SBP ≥130 mm Hg and SBP ≤180 mm Hg at both screening and randomization visit, as described in the protocol
• • 2. ≥ 40 and ≤85 years on a stable regimen of ≥1 anti-hypertensive therapy for at least 1 month at the time of screening or ≥30 and \<40 years on a stable regimen of ≥3 anti-hypertensive therapies for at least 1 month at the time of screening
• • Key Exclusion Criteria
• • 1. Heart rate \>100 bpm as described in the protocol
• • 2. Body mass index \>45 kg/m2 as described in the protocol
• • 3. Glomerular filtration rate (GFR) \<30 mL/min/1.73m2 at screening as described in the protocol
• • 4. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN) as described in the protocol
• • NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply